Action Points

Authors of recent dermatology clinical guidelines received an average of more than $150,000 in industry payments, which were not properly disclosed more than half the time.

The study suggests that the American Academy of Dermatology policies may benefit from strict enforcement or the adoption of new standards.

Authors of recent dermatology clinical guidelines received an average of more than $150,000 in industry payments, which were not properly disclosed more than half the time, according to a retrospective review.

The review showed that 40 of 49 authors of three American Academy of Dermatology (AAD) clinical practice guidelines received various types of payments from companies relevant to the guidelines. Total reimbursement for all 49 authors averaged $157,177 for the 3-year period included in the analysis, and the median total was $33,247. Reimbursement included general payments, research funding, and ownership/investment interests.

A total of 22 of 40 authors who accepted industry payments submitted disclosure statements that were inconsistent with the data in the Open Payments provision of the Affordable Care Act. Many of the disclosures also were inconsistent with AAD regulations pertaining to clinical guideline development, Jake X. Checketts, BS, of the Oklahoma State University Center for Health Sciences in Tulsa, and coauthors reported online in JAMA Dermatology.

"Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments," the authors concluded. "The American Academy of Dermatology policies may benefit from strict enforcement or the adoption of new standards."

The author of an accompanying editorial took issue with some of Checketts and colleagues' methods and interpretation but acknowledged that financial conflicts of interest (FCOI) likely do matter and suggested that AAD increase transparency and enforcement of FCOI policies and procedures.

"'We must take nothing for granted,' President Eisenhower said, in encouraging Americans to guard against the influence of the military-industrial complex. The same goes for our specialty's interactions with industry," wrote Kenneth A. Katz, MD, of Kaiser Permanente in San Francisco. "The study by Checketts et al serves as a reminder that physicians and other stakeholders should continue to guard against the potential for ties to industry, including among clinical practice guideline authors, to inappropriately influence the way we take care of our patients."

In a prepared statement, AAD President Henry Lim, MD, said his organization "stands by the strength and accuracy of its clinical guidelines, as well as the regulations in place to minimize the influence of potential conflicts of interest on the guideline process. While we maintain the guidelines studied in this paper were created in compliance with those regulations, we take seriously this issue and continue to evaluate and refine our guidelines process to address both real and perceived conflicts of interest."

Noting that clinical guideline authors are "the foremost experts in their field," Lim said the they often work with companies that support "cutting-edge research in that field. In evaluating potential conflicts of interest among guidelinies authors, the AAD does not consider research activities to be conflicts."

Lim also pointed out that Checketts and colleagues acknowledged they had no way of knowing whether the payments had any influence on the guideline authors.

"The authors did not assess the potential relevancy of the payments data they compiled, aside from determining whether companies manufactured products related to the guidelines; in doing so, they make the assumption that the physicians' relationships are connected to those products, when those relations could in fact be completely unrelated. Further, the authors acknowledge potential inaccuracies in the Open Payments data and the possibility of these inaccuracies being compounded by human error."

Checketts and colleagues compared disclosure information provided in the guidelines with financial information the 49 guideline authors submitted to Open Payments for the years 2013 to 2016. The Open Payments data also provided the basis for evaluating AAD adherence to the academy's Administrative Regulations. The evaluation included four key aspects of the regulations:

A minimum of 51% of a working group with no relevant FCOI

A chair without any FCOI, except when person's "expertise and leadership is deemed necessary" by the AAD

Disclosure updates by all members of a working group

Recusal of a working group member from activities relevant to an FCOI

The analysis showed that 81.6% (40 of 49) of the authors reported at least one industry payment, including 18 who received payments exceeding $50,000 (12 accepting payments >$100,000). Payments for the 49 authors totaled $7,701,681 for 2013 to 2015.

In accordance with Open Payments, the payments were categorized as general (consulting fees, honoraria, travel, etc.), research, and associated research (such as funding for a project for which an physician is identified as the principal investigator). General payments averaged $83,703, research payments $11,250, and associated research payments $302,128.

Disclosure information included in the guidelines was discrepant with Open Payments data for 55% of the 40 authors who received industry payments, including six authors who reported no FCOI despite receiving payments. Undisclosed payments ranged from $1,000 to $250,000 and included payments for research, travel and lodging, education, consulting, and "other" fees.

Checketts and colleagues called for more detailed reporting in disclosure statements submitted by guideline authors and greater vigilance by the AAD in enforcing the organization's regulations related to authors of clinical guidelines.

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